lutetium Lu 177 vipivotide tetraxetan (Pluvicto): FDA status
Approved Approved Jul 31, 2026. Indication: PSMA positive metastatic hormone sensitive prostate cancer in combination with ARPI.
Regulatory history
- Jul 31, 2026: Label expanded. FDA approved Pluvicto plus an androgen receptor pathway inhibitor for PSMA positive metastatic androgen pathway modulation naive or sensitive prostate cancer based on PSMAddition trial rPFS benefit. oncologytube.com
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